1. Pancreatic Enzyme Delivery (PED) Device Group Members: Todd Dhavale Erica Osadzinski Erica Osadzinski Advisor: Dr. Dennis Stokes

2. What is Cystic Fibrosis (CF)? n Inherited disease which causes exocrine (outward secreting) glands in the body to fail to function normally. n Mucus-producing exocrine glands often produce thick, sticky secretions which plug-up ducts and other passageways. n This occurs in the lungs and intestines and interferes with breathing and digestion.

3. Patients with Cystic Fibrosis: n Suffer from nutritional problems n Do not gain weight properly n Have improper pancreatic function n Need pancreatic enzymes to help digest food: –protease –amylase – lipase

4. Effects of Cystic Fibrosis on Digestion n Occurs in 8 out of 10 of all CF patients n Pancreatic enzymes do not reach intestinal tract n Patients do not gain weight n Malabsorption occurs--growth impairment n Therefore, above average caloric intake is needed along with supplemental enzymes

5. PED Device is designed to: n Deliver commercially available pancreatic enzymes directly to intestinal tract n Deliver enzymes to patients receiving overnight supplemental feedings via a gastrostomy tube

6. Past Work: n Researched pancreatic enzymes function n Observed CF patients in Vanderbilt Children's Hospital n Assessed the current methods of obtaining the necessary pancreatic enzymes n Met with pharmacist for advice and recommendations

7. Current Work: n Testing microsphere stability in the fluid delivery vehicle n Determining the minimum fluid vehicle volume necessary for overnight enzyme delivery n Investigating the capabilities of available pumps, both injection and peristaltic.

8. Future Work: n Integrate pump fittings with connectors to gastrostomy tube (G-Tube) n Formulate limited Human Trials to evaluate the effectiveness of PED delivered enzymes n Obtain funding from Solvay Pharmaceutical to improve the current crude PED model